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What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well.
  • Adults with active psoriatic arthritis in whom methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well.

XELJANZ is also used to treat:

  • Adults with moderately to severely active ulcerative colitis.

It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with hepatitis B or C.

XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.

Important Safety Information & Indications

 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

Your healthcare provider should test you for TB before starting and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.

Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you:

think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired

are being treated for an infection

get a lot of infections or have infections that keep coming back

have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections

have TB, or have been in close contact with someone with TB

live or have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ/XELJANZ XR. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common

have or have had hepatitis B or C

After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

Cancer and immune system problems. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, have happened in patients taking XELJANZ/XELJANZ XR. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to check for the following side effects:

changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.

low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.

low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not receive XELJANZ/XELJANZ XR if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

Before taking XELJANZ/XELJANZ XR, tell your healthcare provider about all of your medical conditions, including if you:

have an infection

have liver problems

have kidney problems

have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines, or narrowing within your digestive tract

have had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR

have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines

plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.

Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ/XELJANZ XR, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll

plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

Tell your healthcare provider about all of the medicines you take, especially any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.

Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Taking XELJANZ/XELJANZ XR

Take XELJANZ 2 times a day with or without food.

Take XELJANZ XR 1 time a day with or without food for rheumatoid or psoriatic arthritis. Do not take XELJANZ XR for ulcerative colitis.

When you take XELJANZ XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

For the treatment of psoriatic arthritis, take XELJANZ/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

What are other possible side effects of XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR may cause serious side effects, including hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects of XELJANZ/XELJANZ XR in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

What is XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well.

Adults with active psoriatic arthritis in whom methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well.

XELJANZ is also used to treat:

Adults with moderately to severely active ulcerative colitis.

It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with hepatitis B or C.

XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

 

Contact Us

If you have questions, concerns or comments, please call our XELJANZ Information Center toll-free at 1-844-935-5269 Monday through Friday, 8:00 AM–8:00 PM ET.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088. By clicking on this link, you will be leaving UC.XELJANZ.com. This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content and services of this site.

 

CO-PAY CARD TERMS AND CONDITIONS

By using the XELJANZ XR/XELJANZ Instant Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.

  • The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan, available in Puerto Rico, formerly known as “La Reforma de Salud”).
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs.
  • You will receive a maximum benefit of $12,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, with a $0 per month co-pay. After a maximum of $12,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • The Card may be used once per month for the life of the program.
  • You must deduct the value of this coupon from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • The Card is not health insurance.
  • The Card is not valid where prohibited by law.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • Pfizer reserves the right to rescind, revoke or amend the program without notice.
  • No membership fee.
  • Card and Program expires 12/31/2018.

If you have questions or are in need of additional support, call 1-844-XELJANZ (1-844-935-5269) or visit www.XELJANZ.com.

 

XELSOURCE TERMS & CONDITIONS/ELIGIBILITY REQUIREMENTS

PFIZER PATIENT ASSISTANCE PROGRAM/ ELIGIBILITY REQUIREMENTS

  • The Pfizer patient assistance program is available for eligible uninsured and underinsured patients.
  • Program is only available to patients who meet financial and other criteria.
  • This Program does not require, nor will it be made contingent on, purchase requirements of any kind.
  • No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Program good only in the U.S. and Puerto Rico.
  • Patient must be a resident of the United States or Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the U.S. or Puerto Rico.

TRIAL Rx PROGRAM TERMS & CONDITIONS

  • Trial Rx is not health insurance and is a one-time offer for eligible, commercially insured patients only.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ XR/XELJANZ.
  • Patients who have already begun therapy with XELJANZ XR/XELJANZ at the time of the request and patients under the age of eighteen (18) years of age are ineligible for participation in the Program.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, Missouri, Ohio, or Rhode Island.
  • Available in 14-day supply.
  • This offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Trial Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed.
  • Offer good only in the US and Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
INTERIM CARE PRESCRIPTION PROGRAM TERMS & CONDITIONS
  • Interim Care Prescription is not health insurance and is available for eligible, commercially insured patients only.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ XR/XELJANZ.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, Missouri, Ohio, or Rhode Island.
  • Available in 14- and 28-day supplies. Refills are subject to limitations.
  • Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
  • Offer good only in the US and Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
HARDSHIP ASSISTANCE PROGRAM CO-PAY CARD TERMS & CONDITIONS

By using the XELSOURCE Hardship Assistance Program Co-pay Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the terms & conditions described below:

  • The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico, formerly known as “La Reforma de Salud”).
  • The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs.
  • The Card will pay your deductible, co-payment or co-insurance amount up to a maximum amount of $10,000 per calendar year.
  • The Card may be used once per month for the life of the program.
  • You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • Cannot be combined with any other rebate/coupon, free trial or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • The Card is not health insurance.
  • The Card is not valid where prohibited by law.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to one 1 per person during this offering period and is not transferable.
  • Pfizer reserves the right to rescind, revoke or amend the program without notice.
  • The Card and Program expire 12/31/2018.
CO-PAY CARD TERMS AND CONDITIONS

By using the XELJANZ XR/XELJANZ Instant Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.

  • The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan, available in Puerto Rico, formerly known as “La Reforma de Salud”).
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs.
  • You will receive a maximum benefit of $12,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, with a $0 per month co-pay. After a maximum of $12,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • The Card may be used once per month for the life of the program.
  • You must deduct the value of this coupon from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • The Card is not health insurance.
  • The Card is not valid where prohibited by law.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • Pfizer reserves the right to rescind, revoke or amend the program without notice.
  • No membership fee.
  • Card and Program expires 12/31/2018.

If you have questions or are in need of additional support, call 1-844-XELJANZ (1-844-935-5269) or visit www.XELJANZ.com.

Questions: 
What should I do if my pharmacy does not accept the Co-Pay Savings Card?
Body: 

If you are eligible for the Co-Pay Savings Card, but your pharmacy does not accept it, a rebate form is available to reimburse you for the co-pay amount. Instructions on how to redeem are included on the form. Terms and conditions/eligibility requirements apply.

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